This research conference, to be held December 8-9, 2001, will examine and develop a framework for articulating the epistemology of and ethical dilemmas produced by quality improvement (QI) efforts so as to suggest if current processes and procedures for protecting human research subjects are appropriately applied to QI work. The specific aims are to: 1. Articulate the major arguments about the nature of the knowledge that can be gained from quality improvement efforts and standards for assessing its validity. 2. Examine the potential risks, benefits and harms of QI and determine what levels of benefit are necessary, as well as what levels of risk are acceptable, for the performance of QI work. 3. Identify privacy concerns and informed consent considerations that arise from QI work. 4. Identify priority areas for research on the conceptual, ethical and empirical dimensions of quality improvement especially in areas that have specific importance in the regulation of QI with respect to protection of human subjects. The approximately 30 participants at the invitational conference will include: clinical researchers; health services researchers; researchers in anthropology, qualitative sociology and educational innovation; medical, nursing and allied health professionals engaged in QI; medical administrators with oversight roles in QI projects; risk managers; IRB members; ethicists; patient advocates; and government representatives (e.g. AHRQ). To develop the conference agenda, finalize the list of speakers and outline the conceptual issues to be discussed in the invited papers, a meeting of the planning committee will be held on July 15, 2000 at RAND offices in Arlington, VA. Four papers and a review of the literature will be commissioned for discussion as part of the conference agenda. After the conference, a manuscript synthesizing the conference insights on specific questions and methodological approaches will be prepared by Joanne Lynn, MD, Bruce Jennings, MA, Melissa M. Bottrell, MPH, PhDc, and other members of the planning committee. The manuscript will be submitted to professional journal and be made available on the World Wide Web. At least one presentation will be made at a professional meeting concerned with bioethics and research regulation.